FDAClass IINovember 27, 2019

Altacaine recall: Sterility Concern

Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC…

Why was Altacaine recalled?

Lack of Assurance of Sterility

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

17205 07/19 08/31/2017 17206 07/19 09/13/2017 17271 09/19 11/08/2017 18003 01/20 03/06/2018 18097 04/20 05/11/2018 18166 07/20 07/26/2018 18227 09/20 10/05/2018 18246 10/20 11/16/2018 18317 12/20 12/18/2018 19080 03/21 04/22/2019 19106 04/21

Product
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution, USP, 0.5%, 15 mL, Rx only, Mfd. by: Altaire Pharmaceuticals Inc. Aquebogue, NY 111931, NDC…
Recalling firm
Altaire Pharmaceuticals, Inc.
Quantity
306,479 units
Distribution
U.S.A. Nationwide
Recall date
November 27, 2019
Classification
Class II
Status
Completed
Agency
FDA (drug)
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